deramiocel

all catalysts(0)

nothing on the calendar yet

News(10)

• US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump
  In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as…
  biospace · 10d ago
• Mikhail, Davis on board with regulatory framework tailored to rare disease therapies
  Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease therapies. If approved by the…
  biospace · 14d ago
• Capricor, Replimune illustrate why FDA must listen to rare disease specialists
  Last month’s FDA advisory committee meetings for therapies developed by Capricor Therapeutics and Replimune effectively illustrate the different outcomes for patients when the agency prioritizes sp…
  biospace · 1mo ago
• Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealed
  FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based c…
  biospace · 1mo ago
• Capricor secures reprieve as FDA extends DMD cell therapy review
  The FDA has extended its review of Capricor Therapeutics’ Duchenne muscular dystrophy drug candidate, deferring the decision to review information the biotech submitted after a negative advisory co…
  fiercebiotech · 1mo ago
• FDA extends review of Capricor cell therapy; Pain drug startup to go public
  The agency is now reviewing an updated application for deramiocel with a “refined” indication. Elsewhere, a startup co-founded by Vivek Ramaswamy is taking a speedy path to the public markets.
  biopharma_dive · 1mo ago
• Capricor’s Duchenne therapy has new life after FDA grants 3-month extension
  The FDA has granted a three-month extension for Capricor Therapeutics’ Duchenne muscular dystrophy hopeful deramiocel in order to review additional data and consider a refined indication. The new t…
  biospace · 1mo ago
• FDA delays Capricor's deramiocel PDUFA date to review new data
  The FDA is pushing back its decision on Capricor Therapeutics’ problematic Duchenne muscular dystrophy therapy to review additional data for a more niche indication. The company on Monday said the…
  endpoints · 1mo ago
• Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand alone
  Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t ne…
  biospace · 1mo ago
• Capricor investor calls for change as company awaits decision on Duchenne candidate
  Kaos Capital in a letter to other Capricor Therapeutics shareholders called for “an immediate meeting, board change, and capital-preservation plan.” The biotech recently put all other pipeline work…
  biospace · 1mo ago